The following data is part of a premarket notification filed by Beijing Huatai Healthcare Technology Co., Ltd. with the FDA for Infrared Therapy System.
| Device ID | K142340 |
| 510k Number | K142340 |
| Device Name: | Infrared Therapy System |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | Beijing Huatai Healthcare Technology Co., Ltd. Rm.216, No.2 Building, No.18, Qinghe Anningzhuang East Road Haidian District Beijing, CN 10085 |
| Contact | Bingxian Zheng |
| Correspondent | Helen Nan Wenzhou Cytech Information Service Co., Ltd. Room302, NO.21 Building, Kaiyu Garden, Xishan South Road Wenzhou, Zhejiang, CN 325000 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-21 |
| Decision Date | 2014-12-02 |
| Summary: | summary |